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Phase II clinical trial demonstrates successful drug repurposing of a histamine H1-receptor antagonist for antiviral prophylaxis

In a randomized placebo-controlled phase II clinical trial that included 450 participants, we have demonstrated that the incidence of PCR-confirmed SARS-CoV-2 infections was significantly lower with application of a nasal spray containing the histamine H1-receptor antagonist azelastine compared with placebo treatment. 

Our study indicates that drug repurposing is a cost-effective and time-efficient approach that facilitates the discovery of new therapeutic options against viral diseases.

 

Reference

Lehr T, et al, Smola S, Bals R; The CONTAIN Study Group. Azelastine nasal spray for prevention of SARS-CoV-2 infection: a phase 2 randomized clinical trial. JAMA Intern Med. Published online September 2, 2025. doi:10.1001/jamainternmed.2025.4283

Comment in 

https://jamanetwork.com/journals/jamainternalmedicine/fullarticle/2838339

Trial registration  
EudraCT number: 2022-003756-13

Press releases

https://nachrichten.idw-online.de/2025/09/02/klinische-studie-nasenspray-mit-wirkstoff-azelastin-verringert-risiko-einer-corona-infektion-um-zwei-drittel?groupcolor=3

https://www.uni-saarland.de/aktuell/dreimal-spruehen-nie-wieder-corona-39490.html

https://www.uni-saarland.de/aktuell/nasenspray-azelastin-wirkung-corona-39343.html